Catalog Number

VBT1310

Brand Name

AVAmax

Version/Model Number

VBT1310

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

5d975a59-7b3d-4e26-b04c-a6e64cd0c55c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 19, 2017

Package DI Number

50885403240896

Quantity per Package

5

Contains DI Package

10885403240898

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS